Automated Macrodissection Device

自动宏观解剖装置

• 批准号: 8313696
• 负责人: Nils B Adey
• 金额: $ 14.77万
• 依托单位: AVANSCI BIO, LLC
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-07-01 至 2012-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8313696
• 关键词: Applications Grants; Area; Aspirate substance; Automation; Biological Assay; Biological Models; Cancer Diagnostics; Clinical; Computer software; Computerized Medical Record; Computers; Consultations; DNA; Development; Devices; Diagnosis; Discipline; Dissection; Documentation; Effectiveness; Excision; Formalin; Glass; Goals; Head; Heterogeneity; Histocompatibility Testing; Histopathology; Image; Investments; Laboratories; Licensing; Liquid substance; Malignant Neoplasms; Manuals; Marketing; Mechanics; Methods; Microdissection; Microscope; Microscopic; Molecular; Monitor; Motor; Movement; Mutation; Nucleic Acids; Optics; Paraffin Embedding; Pathologist; Pathology; Performance; Phase; Positioning Attribute; Procedures; Process; Productivity; Protocols documentation; RNA; Recovery; Reporting; Research; Resolution; Retrieval; Risk; Robotics; Sampling; Secondary to; Slide; Small Business Innovation Research Grant; Specificity; Staging; Stratification; Surface; System; Techniques; Technology; Testing; Thick; Tissues; Tube; Universities; Utah; Validation; Walking; Work; anticancer research; base; commercialization; design; digital; digital imaging; improved; instrument; interest; laser capture microdissection; new technology; novel; prototype; response; sample fixation; software systems; treatment planning

DESCRIPTION (provided by applicant): Microscopic examination of formalin fixed, paraffin embedded (FFPE) tissue sections mounted on glass slides is the cornerstone of clinical histopathology. Ancillary molecular testing is often required for diagnosis, risk stratification, ad treatment planning, particularly in cancer. Molecular testing often involves mutation or expression analysis of nucleic acids (DNA and RNA) recovered from FFPE tissue sections. Due to tissue heterogeneity, nucleic acids are often isolated from dissected regions of the FFPE tissue section using current dissection methods, including: Manual Macrodissection, Manual Microdissection, and Laser Capture Microdissection (LCM). This Phase I grant application is for the development of an Automated Macrodissection Device for clinicians that significantly advances productivity and quality of results ahead of existing competitive devices and methods. The goal of the proposed Phase I project is to develop a novel system that encompasses a software application and user interface that will allow a pathologist to indicate an area of interet on a digital image of a tissue section. The software will transfer that area of interest to secondary slides on a new fully automated 12 slide tissue removal and recovery instrument. The new instrument will be a computer controlled system that will includes x.y.z positioning, integrated optics, and multiple choices of specialized tissue removal and recovery tips. Using image recognition the system will automatically identify the tissue section area of interest on the secondary slide, move the specialized tip over this area to displace tissue fragments from the slide surface, and simultaneously recover the liquid containing the suspended tissue section fragments for the ancillary molecular testing. The system will be based on dissection technology co.invented and exclusively licensed from the University of Utah's ARUP Laboratories. The subsequent commercial instrument would fill the need in the clinical market for a high throughput macrodissection (down to 0.25mm resolution) instrument with full automation, process monitoring and reporting, ease of use, with the recovery efficiency of manual dissection techniques, but with far better precision. The system will be validated for tissue image recognition capability, slide to slide scaling and registration, and the capability for integrationto primary digital pathology imaging systems. The system will also be validated for mechanical automation performance including both slide fiducial and automated x.y.¿ correction protocols for 12 slides as well as automated consumable loading and sample handling. Ultimately, the system will also be validated for dissection resolution, efficiency, and accuracy of tissue recovery. Validation strategies are defined based on a model system of digitally imaging system, 12 slide batches, and a defined set of tissue types and slide types. By quantifying the imaging, mechanical and dissection performance in Phase I on prototype instruments, we will demonstrate feasibility for Phase II development and commercialization. PUBLIC HEALTH RELEVANCE: The Automated Macrodissection Device will provide a highly affordable automated system for integrated digital slide imaging and walk-away tissue dissection and recovery for up to twelve slides per batch. The integrated imaging will expedite pathologist review of slides requiring microdissection and will enable consultation with expert pathologists via digital pathology. The system will improve process documentation and verification, enhancing the efforts toward electronic medical records. The device's technical performance includes a dissection resolution down to 0.25mm and an order of magnitude lower investment than that required for laser capture microdissection technologies, enabling much broader access to the new technology. The new device will promote productivity and quality of results for clinicians working in cancer diagnostics, as well as diverse areas of cancer and non-cancer research requiring high throughput tissue dissection from slides.

描述（由申请方提供）：固定在载玻片上的福尔马林固定、石蜡包埋（FFPE）组织切片的显微镜检查是临床组织病理学的基础。辅助分子检测通常用于诊断、危险分层、治疗计划，特别是癌症。分子检测通常涉及从FFPE组织切片中回收的核酸（DNA和RNA）的突变或表达分析。由于组织异质性，核酸通常使用当前的解剖方法从FFPE组织切片的解剖区域分离，所述解剖方法包括：手动宏观解剖、手动显微解剖和激光捕获显微解剖（LCM）。该第一阶段拨款申请用于为临床医生开发自动宏观解剖设备，该设备大大提高了现有竞争设备和方法的生产率和结果质量。拟议的第一阶段项目的目标是开发一种新的系统，包括一个软件应用程序和用户界面，将允许病理学家指示组织切片的数字图像上的感兴趣区域。该软件将把感兴趣的区域转移到新的全自动12载玻片组织切除和回收仪器上的二级载玻片上。新的仪器将是一个计算机控制系统，将包括x.y.z定位，集成光学，和多种选择的专门组织切除和恢复提示。使用图像识别，系统将自动识别组织切片上的感兴趣区域。 第二载玻片，在该区域上移动专用尖端以从载玻片表面置换组织碎片，并且同时回收包含悬浮的组织切片碎片的液体用于辅助分子测试。该系统将基于解剖技术公司发明和独家授权的犹他州大学的ARUP实验室。随后的商业仪器将满足临床市场对高通量宏观解剖（分辨率低至0.25 mm）仪器的需求，该仪器具有全自动化、过程监测和报告、易用性、手动解剖技术的恢复效率，但精度更高。将对系统的组织图像识别能力、载玻片间缩放和配准以及与主要数字病理学成像系统集成的能力进行确认。该系统还将验证机械自动化性能，包括载玻片基准和自动x. y。12个载玻片的校正方案以及自动消耗品加载和样本处理。最终，还将对该系统的解剖分辨率、效率和组织恢复的准确性进行验证。根据数字成像系统的模型系统、12个载玻片批次以及一组定义的组织类型和载玻片类型定义确认策略。通过量化第一阶段原型器械的成像、机械和解剖性能，我们将证明第二阶段开发和商业化的可行性。 公共卫生关系：自动宏观解剖设备将提供一个非常经济实惠的自动化系统，用于集成数字载玻片成像和步行组织解剖和回收，每批多达12个载玻片。集成成像将加快病理学家对需要显微切割的载玻片的审查，并将通过数字病理学与专家病理学家进行咨询。该系统将改进过程文件和核查，加强电子病历的努力。该设备的技术性能包括切割分辨率低至0.25 mm，并且比激光捕获显微切割技术所需的投资低一个数量级，从而能够更广泛地获得新技术。新设备将提高癌症诊断临床医生的生产力和结果质量，以及需要从载玻片上进行高通量组织解剖的癌症和非癌症研究的各个领域。